CompletedPhase 4Results posted

A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

255

Study population

Type 2 diabetes

Eligibility highlights

•BMI 20-45•HbA1c 7.1-9%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00870194

Org study IDH8O-CR-GWDK

Timeline

Milestones

Study first posted2009-03-27estimated

Results first posted2011-06-17estimated

Last update posted2015-04-09estimated

Study start2009-03 (month precision)

Primary completion2010-04actual (month precision)

Study completion2010-04actual (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Present with type 2 diabetes

•Patients have been treated with a stable dose of the following for at least 3 months prior to screening:

-100 mg/day sitagliptin and

-≥1500 mg/day metformin, or maximum tolerated dose (extended release or immediate-release).

•Have inadequate glycemic control as evidenced by an HbA1c between 7.1% and 9%, inclusive.

•Have a body mass index (BMI) ≥20 kg/m2 and <45 kg/m2

Exclusion criteria

•Are currently enrolled in, or discontinued within the last 30 days (or longer, if local guidelines require) from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.

•Have previously completed or withdrawn from this study or any other study investigating exenatide.

•Have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin.

•Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 1 month of screening.

•Are currently treated with any of the following excluded medications:

-Thiazolidinediones (TZD) within 3 months of screening.

-Sulfonylurea (SU) within 3 months of screening.

-Dipeptidyl peptidase-4 [DPP-4] inhibitors, with the exception of sitagliptin, within 3 months of screening.

-Meglitinide derivatives (for example, repaglinide or nateglinide) within 3 months of screening.

-Alpha-glucosidase inhibitors (for example, miglitol or acarbose) within 3 months of screening.

-Exogenous insulin within the 3 months prior to screening.

-Drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride, and chronic macrolide antibiotics.

-Systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous (IV), or intramuscular (IM) route used regularly (for longer than 1 month) or used within 1 month immediately prior to screening.

-Any other oral antidiabetic (OAD) agent, other than sitagliptin or metformin, within 3 months prior to screening.

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Cardiometabolic biomarkers

Safety / tolerability / PK

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Change in Body Weight (kg)

Time frame:Baseline to 20 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Least-squares mean · kg	95% CI
Exenatide + Placebo	-2.58	-
Exenatide + Sitagliptin	-2.20	-

p.266Mixed Model Repeated Measures

Secondary/protocol endpoint

Change in Waist Circumference (cm)

Time frame:Baseline to 20 Weeks

Waist circumference, change

change from baseline, improvement

Posted result

Group	Least-squares mean · cm	95% CI
Exenatide + Placebo	-3.25	-
Exenatide + Sitagliptin	-2.36	-

p.095Mixed Model Repeated Measures

Secondary/protocol endpoint

Waist-to-Hip Ratio

Time frame:Baseline to 20 Weeks

change from baseline, improvement

Posted result

Group	Least-squares mean · Ratio	95% CI
Exenatide + Placebo	-0.01	-
Exenatide + Sitagliptin	-0.00	-

p.567Mixed Model Repeated Measures

Glycemic / diabetes

6 endpoints

Primary/protocol endpoint

Change in HbA1c (Percent)

Time frame:Baseline to 20 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · Percent HbA1c	95% CI
Exenatide + Placebo	-0.38	-
Exenatide + Sitagliptin	-0.68	-

p.012Mixed Model Repeated Measures

Least square mean difference0.3095% CI0.07 - 0.53p.012Mixed Model Repeated Measures

Power calculation: 80% assuming 200 patients (100 in each arm), no true difference and 1.0% standard deviation.

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c <=7.0%

Time frame:Baseline to 20 Weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c <7.0%

Time frame:Baseline to 20 Weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c <=6.5%

Time frame:Baseline to 20 Weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · Percentage	95% CI
Exenatide + Placebo	16.5	-
Exenatide + Sitagliptin	20.7	-

p.480Fisher's Exact Test

Secondary/protocol endpoint

Change in FSG (mmol/L)

Time frame:Baseline to 20 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · mmol/L	95% CI
Exenatide + Placebo	0.06	-
Exenatide + Sitagliptin	-0.55	-

p.038ANCOVA

Secondary/protocol endpoint

SMBG (mmol/L)

Time frame:Baseline to 20 Weeks

change from baseline, improvement

Posted result

Group	Least-squares mean · mmol/L	95% CI
Exenatide + Placebo	8.57	-
Exenatide + Sitagliptin	8.16	-

p.207Mixed Model Repeated Measures

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Change in Triglycerides (mmol/L)

Time frame:Baseline to 20 Weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Least-squares mean · mmol/L	95% CI
Exenatide + Placebo	0.17	-
Exenatide + Sitagliptin	-0.07	-

p.055ANCOVA

Secondary/protocol endpoint

Change in HDL (mmol/L)

Time frame:Baseline to 20 Weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Least-squares mean · mmol/L	95% CI
Exenatide + Placebo	-0.03	-
Exenatide + Sitagliptin	-0.01	-

p.269ANCOVA

Secondary/protocol endpoint

Change in LDL (mmol/L)

Time frame:Baseline to 20 Weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Least-squares mean · mmol/L	95% CI
Exenatide + Placebo	0.06	-
Exenatide + Sitagliptin	0.10	-

p.622ANCOVA

Secondary/protocol endpoint

Change in Total Cholesterol (mmol/L)

Time frame:Baseline to 20 Weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Least-squares mean · mmol/L	95% CI
Exenatide + Placebo	0.09	-
Exenatide + Sitagliptin	0.08	-

p.888ANCOVA

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Incidence of Hypoglycemia (Overall)

Time frame:Baseline to 20 Weeks

event count, event

Posted result

Group	Number · Participants	95% CI
Exenatide + Placebo	5	-
Exenatide + Sitagliptin	10	-

p.287Fisher's Exact Test

Secondary/protocol endpoint

Incidence of Severe Hypoglycemia(Overall)

Time frame:Baseline to 20 Weeks

Severe hypoglycemia

event count, event

Posted result

Group	Number · Participants	95% CI
Exenatide + Placebo	1	-
Exenatide + Sitagliptin	0	-

p.498Fisher's Exact Test

Secondary/protocol endpoint

Incidence of Nocturnal Hypoglycemia (Overall)

Time frame:Baseline to 20 Weeks

Documented hypoglycemia

event count, event

Posted result

Group	Number · Participants	95% CI
Exenatide + Placebo	0	-
Exenatide + Sitagliptin	3	-

p.247Fisher's Exact Test

Secondary/protocol endpoint

Incidence of Confirmed Hypoglycemia(Overall)

Time frame:Baseline to 20 Weeks

Documented hypoglycemia

event count, event

Posted result

Group	Number · Participants	95% CI
Exenatide + Placebo	1	-
Exenatide + Sitagliptin	2	-

p1.00Fisher's Exact Test

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

A randomized non-inferiority study comparing the addition of exenatide twice daily to sitagliptin or switching from sitagliptin to exenatide twice daily in patients with type 2 diabetes experiencing inadequate glycaemic control on metformin and sitagliptin.
Diabetic medicine : a journal of the British Diabetic Association2012 Nov (month)PMID22375612doi:10.1111/j.1464-5491.2012.03624.xvia clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.